A Research Study on How NNC0487-0111, a New Medicine, Works in Chinese Participants When Injected Under the Skin.

NCT07121153 | Completed Phase 1

• 2 other identifiers: NN9490-8213U1111-1311-5582
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The study is testing a new medicine (NNC0487-0111) for weight control in Chinese people with BMI between 24 kilogram per meter square (kg/m2) and 34.9 kg/m2. The aim of the study is to see how safe the study medicine is and how it behaves in human body. Participants will either get the study medicine or placebo (a "dummy medicine" similar to the study medicine but without active ingredients) and which treatment they get is decided by chance. The study medicine is a potential new medicine which cannot be prescribed by doctors but has previously been tested in humans. This study will last for up to 53 days.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (1)

• Number of treatment emergent adverse events (TEAEs)

  Number of events

  From NNC0487-0111 administration (Day 1) to completion of the end of study visit (Day 23)

Secondary Outcomes (6)

• AUC0-∞,SD; the area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose

  From pre-dose on Day 1 until completion of the end of study visit (Day 23)

• Cmax,SD; the maximum plasma concentration of NNC0487-0111 after a single dose

  From pre-dose on Day 1 until completion of the end of study visit (Day 23)

• tmax,SD; the time of maximum plasma concentration of NNC0487-0111 after a single dose

  From pre-dose on Day 1 until completion of the end of study visit (Day 23)

• t1/2,SD; the terminal half-life of NNC0487-0111 after a single dose

  From pre-dose on Day 1 until completion of the end of study visit (Day 23)

• Relative change in body weight

  From baseline Day 1 until completion of the end of study visit (Day 23)

Study Arms (3)

Cohort A1

EXPERIMENTAL

Cohort A1 will include 12 participants randomised (3:1), with 9 participants being randomised to receive a single dose level 1 of active treatment and 3 participants randomised to receive placebo.

Drug: NNC0487-0111 A; Drug: Placebo A

Cohort A2

EXPERIMENTAL

Cohort A2 will include 12 participants randomised (3:1), with 9 participants being randomised to receive a single dose level 2 of active treatment and 3 participants randomised to receive placebo.

Drug: NNC0487-0111 A; Drug: Placebo A

Cohort A3

EXPERIMENTAL

Cohort A3 will include 12 participants randomised (3:1), with 9 participants being randomised to receive a single dose level 3 of active treatment and 3 participants randomised to receive placebo.

Drug: NNC0487-0111 A; Drug: Placebo A

Interventions

Placebo A DRUG

Participants will receive single dose (level 1, level 2, level 3) injection of placebo A subcutaneoulsy.

Cohort A1; Cohort A2; Cohort A3

NNC0487-0111 A DRUG

Participants will receive single dose (level 1, level 2, level 3) injection of NNC0487-0111 A subcutaneoulsy.

Cohort A1; Cohort A2; Cohort A3

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
• Male Chinese participants, age 18-55 years (both inclusive) at the time of signing the informed consent.
• Body mass index between 24.0 and 34.9 kg/m2 (both inclusive) at screening. Overweight and obesity should be due to excess adipose tissue, as judged by the investigator, with a body weight (more than or equal to) ≥ 65.0 kg at screening.
• Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

You may not qualify if:

• Any condition, unwillingness or inability which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
• HbA1c ≥ 6.5 percent (%) \[48 milimol per mole (mmol/mol)\] at screening.
• Any laboratory safety parameters at screening outside the below laboratory ranges:
• Vitamin D (25-hydroxycholecalciferol) less than (\<) 12 nanogram per mililiter (ng/mL) \[30 nanometer (nM)\] at screening
• Parathyroid hormone (PTH) outside normal range at screening
• Total calcium outside normal range at screening
• Amylase ≥ 2 times upper limit of normal at screening
• Lipase ≥ 2 times upper limit of normal at screening
• Calcitonin ≥ 50 picogram per mililiter (pg/mL) at screening

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Jinan Central Hospital

Jinan, Shandong, 250000, China

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Transparency dept. 2834

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 13, 2025
• Study Start: August 11, 2025
• Primary Completion: December 20, 2025
• Study Completion: December 20, 2025
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)